Job Description
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Role Description: The Senior Manufacturing Engineer will be a key contributor on Bolt’s Manufacturing team, developing a therapeutic medical device.
Responsibilities:
- Evaluate existing EDM manufacturing practices , identifying areas for optimization and improvement .
- Lead strategic operations to enhance production capacity and implement more efficient processes .
- Analyze and design sequence of operations and workflows to maximize utilization of production facilities and personnel .
- Oversee manufacturing process development, implementation, and continuous improvement to enhance yield, reduce costs, and improve productivity .
- Lead Lean Manufacturing initiatives, including Value Stream Mapping, Kaizen events, and Six Sigma process improvement projects .
- Apply Six Sigma methodologies ( DMAIC, DMADV ) using tools such as Minitab, FMEA, Fishbone diagrams, and Process Mapping . Black Belt certification preferred .
- Optimize production processes to reduce inefficiencies and improve overall productivity .
- Assess and refine operator tasks and responsibilities , identifying opportunities for workflow improvements and productivity enhancement.
- Ensure accurate documentation of manufacturing processes, including technical reports, lab analyses, and data presentations .
- Develop process improvements aimed at achieving high efficiency and cost-effectiveness .
- Participate in projects focused on product quality enhancements, rework reduction, cost minimization, and performance improvements .
- Analyze workflow layouts, equipment placement, and space utilization to maximize manufacturing efficiency .
- Identify and resolve process-related issues to maintain high-quality production standards .
- Provide daily production support , ensuring on-time delivery of top-tier products .
- Assist in scaling up equipment and processes from prototype development to full-scale manufacturing .
- Offer hands-on process guidance and training to operators , reinforcing technical best practices .
- Troubleshoot production line challenges , addressing concerns related to yield, quality, and throughput .
- Develop, verify, and validate manufacturing operations , ensuring seamless transition from process development to commercialization .
- Lead fixture and tooling design initiatives to streamline manufacturing processes .
- Utilize SolidWorks to design and fabricate fixtures/tooling for production improvement.
- Apply principles of Design for Manufacturing (DFM), Design for Assembly (DFA), Design for Rework (DFR), Design for Six Sigma (DFSS), and Design for Supply Chain (DFSC) .
- Ensure compliance with medical device industry standards , supporting commercialization efforts .
- Operate EDMs, mills, and lathes ; familiarity with G-code is a plus.
- Oversee and enhance automated visual inspection systems , including Keyence, Nikon, and OGP technologies .
Preferred Experience:
- Proven experience in EDM manufacturing or similar machining environment
- Proficiency in SolidWorks with expertise in fixture/tooling design and fabrication
- Experience with DFM (Design for Manufacturing), DFA (Assembly), DFSS (Six Sigma)
- Experience with the Medical Device Industry and the industry requirements to bring products into commercialization.
Qualifications:
Education:
- Bachelor’s Degree or Master’s Degree in Biomedical, Mechanical, or Industrial engineering or a related field.
Required Experience:
- 5+ years of equivalent industry experience and product development.
- Good understanding of Current GMPs and ISO 13485 standards.
- Manufacturing or sustaining experience.
Knowledge, Skills, and Abilities:
- Strong communication and organizational skills.
- Continual improvement process experience.
- Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.
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